BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 11976975 · Received June 10, 2021

    Report

    Report Number
    2016493-2021-508070
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Report Date
    February 12, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2909-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS EVALUATED AND REPAIRED THROUGH THE SERVICE REPAIR PROCESS. UPON VISUAL INSPECTION THE SERVICE TECHNICIAN NOTED THAT THEY REPLACED LOGIC BOARD AND REFLASHED PKB, POLO, AND MAIN SOFTWARE FOR ERROR CODE 810.9030. REPLACED KEYPAD FOR UNRESPONSIVE BUTTONS ON KEYPAD. THE FAILURE CODE OTHE WAS USED TO TRACK THE ALARIS PUMP SOFTWARE VERSION AS RECEIVED FROM THE CUSTOMER AND THE SOFTWARE VERSION WHEN DEVICE WAS SENT BACK TO THE CUSTOMER. IT DOES NOT REFLECT A DEVICE FAILURE OR REPRESENT ANY RISK TO THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 21SEP2018. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. BASED ON THE FINDINGS, SERVICE DETERMINED THAT THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO THE SOFTWARE ISSUE OF THE LOGIC BOARD. A REVIEW OF THE COMPLAINT HISTORY RECORD IN TRACKWISE AND SAP WAS PERFORMED FOR THE SN (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RECEIVED ALARM - ERROR CODES / MESSAGES. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. THIS DEVICE WAS EVALUATED AND REPAIRED THROUGH THE SERVICE REPAIR PROCESS. UPON VISUAL INSPECTION THE SERVICE TECHNICIAN NOTED THAT THEY REPLACED LOGIC BOARD AND REFLASHED PKB, POLO, AND MAIN SOFTWARE FOR ERROR CODE 810.9030. REPLACED KEYPAD FOR UNRESPONSIVE BUTTONS ON KEYPAD. BASED ON THE FINDINGS, SERVICE DETERMINED THAT THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO THE SOFTWARE ISSUE OF THE LOGIC BOARD. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 21SEP2018. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED, WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RECEIVED ALARM - ERROR CODES / MESSAGES. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872851 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1